NCT01519011

Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral Azacitidine

A PHASE 1, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND EFFECT OF FOOD OF A NEW TABLET FORMULATION OF ORAL AZACITIDINE, AND TO EVALUATE THE SAFETY AND EFFICACY OF ORAL AZACITIDINE IN SUBJECTS WITH MYELODYSPLASTIC SYNDROMES, CHRONIC MYELOMONOCYTIC LEUKEMIA OR ACUTE MYELOID LEUKEMIA

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the pharmacokinetics of oral azacitidine when administered once daily as two 150-mg tablets, including the effect of food, and to evaluate the bioavailability of oral azacitidine 300-mg when administered as two 150-mg tablets relative to three 100-mg tablets.

Conditions

• Myelodysplastic Syndromes
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	oral azacitidine	oral azacitidine 300-mg once daily for 3 total doses with two 150-mg tablets (fasted and fed) or three 100-mg tablets (fasted).
DRUG	oral azacitidine	300-mg (three 100-mg tablets) once daily for 21 days of a 28-day cycle.

Timeline

• Start date: 2012-02-07
• Primary completion: 2012-12-31
• Completion: 2015-05-12
• First posted: 2012-01-26
• Last updated: 2019-11-12

Locations

8 sites across 1 country: United States